Researchers from the University of Verona, Italy, were unable to make any conclusions on the role of melatonin in decreasing seizure frequency or improving quality of life in patients with epilepsy. Findings from the meta-analysis are published in the Cochrane Database of Systematic Review

As an update to the Cochrane review from 2012, study authors aimed to assess the efficacy and tolerability of melatonin as add-on therapy for epilepsy as some reports have suggested a possible antiepileptic role. They searched various databases for randomized controlled trials; single, double, or unblinded trials, and parallel group or cross-over studies that evaluated melatonin administration as add-on treatment to any antiepileptic drug (AED) vs. add-on placebo or no add-on treatment. Patients with epilepsy without age, gender, or disability restrictions were included for analysis. 

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Seizure reduction ≥50%, seizure freedom, adverse events, and quality of life were evaluated as outcome measures. A total of six publications enrolling 125 patients were included for the review. Two types of comparisons were available: melatonin vs. placebo and melatonin 5mg vs. melatonin 10mg. The study authors reported that due to insufficient data on the outcomes, they were not able to perform any meta-analyses; they were only able to provide a summary of the data.

Four studies were randomized, double-blind, cross-over, placebo-controlled trials and two were randomized, double-blind, placebo-controlled trials. Two studies reported the exact number of seizures during the trial vs. baseline; no patients with seizures during the trial had a change in frequency vs. baseline. Two studies systematically evaluated adverse effects and only one study systematically evaluated quality of life. The study showed no statistically significant improvement in quality of life in the add-on melatonin group. 

Overall, the authors deemed the reviewed studies to have poor methodological quality with no systematic evaluation of seizure frequency or adverse events, making it “impossible to summarize data in a meta-analysis.” 

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